NCT00119093

Brief Summary

The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

5.8 years

First QC Date

July 8, 2005

Last Update Submit

September 10, 2012

Conditions

HIV Infections

Keywords

Antiretroviral therapyHIVAdherenceViral LoadOpportunistic illness

Outcome Measures

Primary Outcomes (1)

  • Equivalence of 3 different monitoring regimens for ART

Secondary Outcomes (7)

  • Sexual risk behavior

  • medication adherence

  • quality of life

  • depression

  • cost-effectiveness

  • +2 more secondary outcomes

Interventions

Laboratory and clinical monitoring regimensPROCEDURE

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infection
  • CD4 cell count \<250 or symptomatic AIDS
  • Age \>13 years
  • Karnofsky score \>40%
  • AST or ALT \< 5 times normal values
  • Creatinine clearance \>25 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tororo Hospital/CDC-Uganda

Tororo, Tororo, Uganda

Location

Related Publications (4)

  • Ekwaru JP, Campbell J, Malamba S, Moore DM, Were W, Mermin J. The effect of opportunistic illness on HIV RNA viral load and CD4+ T cell count among HIV-positive adults taking antiretroviral therapy. J Int AIDS Soc. 2013 Apr 1;16(1):17355. doi: 10.7448/IAS.16.1.17355.

    PMID: 23547778DERIVED

  • Campbell JD, Moore D, Degerman R, Kaharuza F, Were W, Muramuzi E, Odongo G, Wetaka M, Mermin J, Tappero JW. HIV-infected ugandan adults taking antiretroviral therapy with CD4 counts >200 cells/muL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. doi: 10.1093/cid/cis013. Epub 2012 Mar 14.

    PMID: 22423133DERIVED

  • Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, Downing R, Coutinho A, Solberg P, Alexander LN, Tappero J, Campbell J, Moore DM. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011 Nov 9;343:d6792. doi: 10.1136/bmj.d6792.

    PMID: 22074711DERIVED

  • Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT. Liver enzymes improve over twenty-four months of first-line non-nucleoside reverse transcriptase inhibitor-based therapy in rural Uganda. AIDS Patient Care STDS. 2008 Oct;22(10):787-95. doi: 10.1089/apc.2008.0020.

    PMID: 18778241DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Rebecca E Bunnell, ScD, MEd

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Jonathan H Mermin, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Alex Coutinho, MBChB, MPH

    The AIDS Support Organization

    PRINCIPAL INVESTIGATOR

  • David Moore, MD

    CDC-Uganda and University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Jordan Tappero, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 13, 2005

Study Start

May 1, 2003

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

UG(1)